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[Lancet Respir Med发表论文]:儿科ICU限制胃肠外营养一周不影响远期发育
2019年02月17日 时讯速递, 进展交流 暂无评论

Long-term developmental effects of withholding parenteral nutrition for 1 week in the paediatric intensive care unit: a 2-year follow-up of the PEPaNIC international, randomised, controlled trial

Sören Verstraete, Sascha C Verbruggen, José A Hordijk, et al

Lancet Respir Med 2019; 7: 141-153

Background 背景

The paediatric early versus late parenteral nutrition in critical illness (PEPaNIC) multicentre, randomised, controlled trial showed that, compared with early parenteral nutrition, withholding supplemental parenteral nutrition for 1 week in the paediatric intensive care unit (PICU; late parenteral nutrition) reduced infections and accelerated recovery from critical illness in children. We aimed to investigate the long-term impact on physical and neurocognitive development of early versus late parenteral nutrition.

儿童危重病早期与晚期胃肠外营养研究(PEPaNIC)是一项多中心随机对照研究,结果显示,与早期胃肠外营养相比,在儿科ICU (PICU)限制胃肠外营养一周(晚期胃肠外营养)能够减少危重病患儿的感染,并加速康复。我们旨在研究早期及晚期胃肠外营养对身体及神经认知发育的远期影响。

Methods 方法

In this preplanned 2-year follow-up study, all patients included in the PEPaNIC trial (which was done in University Hospitals Leuven, Belgium; Erasmus Medical Centre–Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) were approached for possible assessment of physical and neurocognitive development compared with healthy children who were matched for age and sex, and who had never been admitted to a neonatal ICU or a PICU. Assessed outcomes comprised anthropometric data; health status; parent-reported or caregiver-reported executive functions and emotional and behavioural problems; and tests for intelligence, visual–motor integration, alertness, motor coordination, inhibitory control, cognitive flexibility, and memory. To address partial responses among the children tested, we did multiple data imputation by chained equations before univariable and multivariable linear and logistic regression analyses adjusted for risk factors. This trial is registered with ClinicalTrials.gov, number NCT01536275.

在这项预先计划的2年随访研究中,所有纳入PEPaNIC研究(在比利时Leuven大学医院,荷兰鹿特丹Erasmus医学中心-Sophia儿童医院,及加拿大埃德蒙顿Stollery儿童医院)的患者均接受身体及神经认知发育评估,并与年龄性别相匹配的健康儿童(从未收入新生儿ICU或PICU)进行比较。评估预后指标包括人体测量数据;健康状况;家长或照护人员报告的执行功能及情绪和行为问题;以及智力、视觉运动整合与记忆力测试结果。为解决测试儿童部分反应的问题,我们在单因素及多因素线性和logistic回归分析对危险因素进行校正前,通过链式方程进行多重数据差补。试验在ClinicalTrials.gov注册,注册号NCT01536275

Findings 结果

At the 2-year follow-up, 60 (8%) of 717 children who received late parenteral nutrition and 63 (9%) of 723 children who received early parenteral nutrition had died (p=0·81). 68 (9%) of 717 children who received late and 91 (13%) of 723 children who received early parenteral nutrition were too disabled for neurocognitive assessment (p=0·059), and 786 patients (395 assigned to late and 391 assigned to early parenteral nutrition) consented for testing. 786 patients and 405 healthy control children underwent long-term outcome testing between Aug 4, 2014, and Jan 19, 2018, and were included in the imputation model for subsequent multivariable analyses. Late parenteral nutrition did not adversely affect anthropometric data, health status, or neurological functioning, and improved parent-reported or caregiver-reported executive functioning (late vs early parenteral nutrition β estimate −2·258, 95% CI −4·012 to −0·504; p=0·011), more specifically inhibition (−3·422, −5·171 to −1·673; p=0·0001), working memory (−2·016, −3·761 to −0·270; p=0·023), and meta-cognition (−1·957, −3·694 to −0·220; p=0·027). Externalising behavioural problems (β estimate −1·715, 95% CI −3·325 to −0·106; p=0·036) and visual–motor integration (0·468, 0·087 to 0·850; p=0·016) were also improved in the late parenteral nutrition group compared with the early parenteral nutrition group. After Bonferroni correction for multiple comparisons, the effect on inhibitory control remained significant (p=0·0001).

在2年随访时,晚期胃肠外营养组717名患儿中60名(8%),以及早期胃肠外营养组723名患者中63名(9%)死亡(p=0·81)。晚期胃肠外营养组717名患儿中68名(9%)及早期胃肠外营养组723名患者中91名(13%)因病无法接受神经认知功能评估(p=0·059),共有786名患者(晚期组395名,早期组391名)同意接受测试。在2014年8月4日至2018年1月19日之间,786名患者与405名健康儿童接受远期预后测试,并纳入后续多因素分析的插补模型。晚期胃肠外营养并不对人口测量学指标,健康状况或神经系统功能产生负面影响,但家长或照护者报告的执行功能改善(晚期与早期胃肠外营养β值−2·258, 95% CI −4·012 to −0·504; p=0·011),特异性抑制更多(−3·422, −5·171 to −1·673; p=0·0001),工作记忆更多(−2·016, −3·761 to −0·270; p=0·023),后设认知更多(−1·957, −3·694 to −0·220; p=0·027)。与早期胃肠外营养组相比,晚期胃肠外营养组外在化行为问题(β值−1·715, 95% CI −3·325 to −0·106; p=0·036)及视觉行为整合(0·468, 0·087 to 0·850; p=0·016)能力改善。在针对多重比较的Bonferroni校正后,对抑制性调控的影响仍然显著(p=0·0001)。

Interpretation 结论

Withholding early parenteral nutrition for 1 week in the PICU did not negatively affect survival, anthropometrics, health status, and neurocognitive development, and improved inhibitory control 2 years after PICU admission.

PICU内限制早期胃肠外营养一周对2年后生存率、人口测量数据、健康状况及神经认知发育没有负面影响,且改善抑制性调控能力。

Funding 资助

European Research Council Advanced Grant, Methusalem programme provided by the Flemish Government, Flemish Agency for Innovation by Science and Technology (IWT), Research Foundation Flanders (FWO), Sophia Children's Hospital Foundation (SSWO), Stichting Agis Zorginnovatie, Erasmus Trustfonds, and European Society for Parenteral and Enteral Nutrition (ESPEN) research grant.

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